Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB
Status: | Active, not recruiting |
---|---|
Conditions: | Other Indications, Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/23/2018 |
Start Date: | January 2016 |
End Date: | December 31, 2018 |
The Impact of Self-Management With Probiotics on Urinary Symptoms and the Urine Microbiome in Individuals With Spinal Cord Injury (SCI) and Spina Bifida (SB)"
As a collaborative effort between MedStar National Rehabilitation Hospital (NRH)/MedStar
Health Research Institute (MHRI), Children's National Medical Center (CNMC) Department of
Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research, and
Georgetown University Medical Center, the overall objective of this study is to develop,
validate, and assess a patient-initiated, probiotics-based, self management protocol that is
initiated at the time of urinary symptoms. The self-management protocol will allow patients
to manage urinary symptoms and avoid potentially unnecessary antibiotic use, and provide a
readily-available means of maintaining health, function, and independence throughout the
lifespan.
Health Research Institute (MHRI), Children's National Medical Center (CNMC) Department of
Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research, and
Georgetown University Medical Center, the overall objective of this study is to develop,
validate, and assess a patient-initiated, probiotics-based, self management protocol that is
initiated at the time of urinary symptoms. The self-management protocol will allow patients
to manage urinary symptoms and avoid potentially unnecessary antibiotic use, and provide a
readily-available means of maintaining health, function, and independence throughout the
lifespan.
Lower urinary symptoms are a common issue for individuals with neurogenic bladder, commonly
occurring in the Spina bifida and Spinal Cord Injury population. In this study, probiotics
will be introduced into the bladder to prevent UTIs. Introduction of probiotics will be
determined by a validated symptom questionnaire (USQ-NB) and protocol (SMP-PRO).
This study will estimate the strength of the associations between successful implementation
of the probiotic self-management program (USQ-NB and SMP-PRO) and urinary symptoms, bladder
inflammation, and the urine microbiome. Investigators will conduct an 18-month study in which
each participant will serve as his/her own control through 3 phases of study: 6-months usual
care (baseline), 6-months probiotic intervention, and 6-months follow-up.
Participants will complete the Urinary Symptom Questionnaire weekly. After 6 months of
baseline data collection, participants will receive the Lactobacillus (Culturelle GG, 20
billion live organisms for adults and 10 billion live organisms for children <18 years of
age), will be instructed on preparation and intravesicular instillation of the Lactobacillus,
and will have a tutorial with a fellow consumer on use of the patient-initiated protocol. The
protocol and Lactobacillus bladder instillation instructions (including a step-by-step video)
will be available on the study website for 24/7 access and written instructions will be
provided at the time of instruction.
For the intravesicular Lactobacillus instillation, participants will be instructed to mix the
contents into sterile saline. After mixing, participants will draw up the liquid
Lactobacillus mixture into a 60cc catheter tip syringe and instill via the intermittent
catheter after fully emptying the bladder. Participants will be instructed not to catheterize
for at least 4 hours after the bladder instillation. Participants will receive 10 Culturelle
GG at the beginning of the treatment phase. At the end of each month, the coordinator or RA
will ask how many remaining tablets the participant has, and if needed dispense the next
supply of 10 tablets. Participants will be instructed to complete the USQ-NB weekly.
If/when urinary symptoms occur, subjects will be instructed to follow the protocol to
determine whether to initiate intravesicular Lactobacillus instillation or be evaluated by a
physician. The self-management protocol will also direct them to discontinue Lactobacillus
instillation or be evaluated by a physician if symptoms remit, persist (after 2
instillations), or worsen. The maximum number of instillations is 2 over 28 hours. If
participants are directed by the self-management protocol to seek medical attention or s/he
feels the need for medical evaluation, s/he will be advised to obtain care as they typically
would by their health care provider. Participants will be supplied with letters to be brought
to their health care provider notifying them of the study and requesting sharing of
urinalysis and urine culture results with the research team. A verified UTI will include
those that resulted in antibiotic treatment by a health care professional. An additional
urine sample for metagenomics will either be left with the health care provider for pick up
by the research team, brought to the research site, or obtained by the RA at a mutually
convenient site.
After completion of the 6-month patient-initiated, self-management protocol intervention
period, participants will monitor symptoms weekly using the USQ-NB for the final 6-month
phase of the 18-month study.
occurring in the Spina bifida and Spinal Cord Injury population. In this study, probiotics
will be introduced into the bladder to prevent UTIs. Introduction of probiotics will be
determined by a validated symptom questionnaire (USQ-NB) and protocol (SMP-PRO).
This study will estimate the strength of the associations between successful implementation
of the probiotic self-management program (USQ-NB and SMP-PRO) and urinary symptoms, bladder
inflammation, and the urine microbiome. Investigators will conduct an 18-month study in which
each participant will serve as his/her own control through 3 phases of study: 6-months usual
care (baseline), 6-months probiotic intervention, and 6-months follow-up.
Participants will complete the Urinary Symptom Questionnaire weekly. After 6 months of
baseline data collection, participants will receive the Lactobacillus (Culturelle GG, 20
billion live organisms for adults and 10 billion live organisms for children <18 years of
age), will be instructed on preparation and intravesicular instillation of the Lactobacillus,
and will have a tutorial with a fellow consumer on use of the patient-initiated protocol. The
protocol and Lactobacillus bladder instillation instructions (including a step-by-step video)
will be available on the study website for 24/7 access and written instructions will be
provided at the time of instruction.
For the intravesicular Lactobacillus instillation, participants will be instructed to mix the
contents into sterile saline. After mixing, participants will draw up the liquid
Lactobacillus mixture into a 60cc catheter tip syringe and instill via the intermittent
catheter after fully emptying the bladder. Participants will be instructed not to catheterize
for at least 4 hours after the bladder instillation. Participants will receive 10 Culturelle
GG at the beginning of the treatment phase. At the end of each month, the coordinator or RA
will ask how many remaining tablets the participant has, and if needed dispense the next
supply of 10 tablets. Participants will be instructed to complete the USQ-NB weekly.
If/when urinary symptoms occur, subjects will be instructed to follow the protocol to
determine whether to initiate intravesicular Lactobacillus instillation or be evaluated by a
physician. The self-management protocol will also direct them to discontinue Lactobacillus
instillation or be evaluated by a physician if symptoms remit, persist (after 2
instillations), or worsen. The maximum number of instillations is 2 over 28 hours. If
participants are directed by the self-management protocol to seek medical attention or s/he
feels the need for medical evaluation, s/he will be advised to obtain care as they typically
would by their health care provider. Participants will be supplied with letters to be brought
to their health care provider notifying them of the study and requesting sharing of
urinalysis and urine culture results with the research team. A verified UTI will include
those that resulted in antibiotic treatment by a health care professional. An additional
urine sample for metagenomics will either be left with the health care provider for pick up
by the research team, brought to the research site, or obtained by the RA at a mutually
convenient site.
After completion of the 6-month patient-initiated, self-management protocol intervention
period, participants will monitor symptoms weekly using the USQ-NB for the final 6-month
phase of the 18-month study.
Inclusion Criteria:
1. Age≥18 years
2. SCI, SB or MS at least 1-year duration
3. Neuropathic bladder, as determined by the attending physician
4. Utilizing intermittent catheterization for bladder management
5. A history of 2 or more UTIs in the past year
6. Community dwelling.
Exclusion Criteria:
1. Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux,
bladder or kidney stones, etc.)
2. Use of prophylactic antibiotics
3. Instillation of intravesicular agents to reduce UTI (i.e., gentamycin)
4. Psychologic or psychiatric conditions influencing the ability to follow instructions
5. Participation in another study in which results would be confounded
6. Pregnant or breastfeeding
7. Individuals with a history of acquired or genetic immunodeficiencies; active, acute or
chronic serious infections (i.g., viral hepatitides, HIV/AIDs)
8. Individuals with cancer/autoimmune disorders
9. Serious allergy to any component or excipients in the live bacterial combination
product
10. No change in neurologic status in the previous 2 weeks
11. Taken antibiotic for any reason in the previous 2 weeks
12. Any patient with history of sensitivity or allergy to ampicillin or tetracycline
13. Current urinary tract infection or urinary tract infection within the previous 2 weeks
(as defined by Infectious Diseases Society of America CAUTI Guidelines, 2010).
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
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